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Trasylol disturbing history and details shown Television News Special

During a segment of 60 minutes in mid-February 2008, details of fund control Blood came to light on the deadly side effects of Trasylol and the failure to observe these events and a very aggressive marketing campaign.

In the 1980s, concern about the potential fatal side effects of Trasylol has been discussed. Dr. Juergen Fischer, director of the Institute of Experimental Medicine, University of Cologne, which incident is serious kidney damage in animals given Trasylol. Trasylol Creator ignore the results of their research on potential side effects fatal. next Shortly thereafter, similar effects were seen in patients receiving the drug in U.S. hospitals. Renal failure, acute renal failure also has been the most common side effect of Trasylol to patients. It is prudent to continued use, a U.S. heart surgeon Dr. High, Nicholas Kouchoukos, has prepared a study about 20 people who had been injected Trasylol. Among those receiving the drug, 13 had problems with kidney function after taking the drug. Ignoring of these results and similar studies, the FDA approved Trasylol in 1993.

Due to the aggressive marketing campaign Bayer, Trasylol was used more often control agent and promoted blood for open heart surgery. Sales of the drug reached $ 300 million in 2005, with projected sales of $ 750 million 2006. Dr. Dennis Mangano, a leader in the field of medical research, concluded a study at the same time, a study that tracked records 5065 patients in 17 countries from Trayslol. Published in the New England Journal of Medicine in January 2006, was the largest Trasylol study ever and ultimately most lighting, which suggests not only an association between patients receiving Trasylol and acute renal inadequate, but also a trend towards increased risk of death hospital.

When Dr. Mangano presented his findings the FDA Advisory Committee, the response has been less dynamic than I had imagined. Since the results Dr. Mangano are based on hospital records of patients rather than a more traditional, involving a placebo, the committee was reluctant to comply with your request withdraw the drug from the market. Without knowledge of the commission, Bayer had the results of a study by Harvard professor Dr. Alexander Walker hired, who examined records of nearly 70,000 patients in the same way that Mr. Mangano has done his research. More surprising were the results strikingly similar to the study Dr. Walker found: patients receiving Trasylol were at increased risk of acute renal failure and death. The failure of Bayer to inform the committee of his findings Dr. Walker was taken to confirm contact with the FDA, emphasizing the fact that Bayer had deliberately concealed potentially damning information to continue Trayslol lucrative sale. However, the only response from the FDA to confirm the deadly side effects will be issued another warning to doctors, would be one years before the full committee will meet again to reassess the effectiveness of drugs.

Meanwhile, a clinical term in Canada in 2007 was interrupted when the participants in the study group began dying. The German government immediately removed and banned Trayslol, through a joint effort between the Government of Canada and the FDA, Bayer has been persuaded to carry out a temporary suspension of the marketing of the deadly drug.

An estimated 4.5 million people have been Trayslol Worldwide, one third of these patients, about 1.5 million people have received the drug in the United States within 14 years, the drug was available. By Dr. Mangano estimates that more than 20,000 lives have been saved from the injection of drugs has been temporarily withdrawn from the market.

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